Core Insights - Immunic, Inc. is a biotechnology company focused on developing orally administered small molecule therapies for chronic inflammatory and autoimmune diseases [2][3] - The company is actively participating in several scientific and industry conferences in May 2025 to present its research and findings [1][2] Conference Participation - Immunic will present two abstracts at the Digestive Disease Week (DDW) from May 3-6, 2025, in San Diego, CA, focusing on its phase 1/1b clinical trial of IMU-856 for celiac disease [2] - A case study on clinical trial supply chain challenges in the Middle East and North Africa (MENA) will be presented at the Clinical Trial Supply Forum 2025 in Brussels, Belgium, from May 13-15, 2025 [2] - The company will also attend the Consortium of Multiple Sclerosis Centers (CMSC) Annual Meeting 2025 in Phoenix, AZ, from May 28-31, 2025, where preclinical data on vidofludimus calcium (IMU-838) will be showcased [2] Product Development - The lead development program, vidofludimus calcium (IMU-838), is in phase 3 clinical trials for relapsing multiple sclerosis, with completion expected in 2026 [3] - IMU-856 targets SIRT6 to restore intestinal barrier function and has potential applications in various gastrointestinal diseases, including celiac disease and inflammatory bowel disease [3] - IMU-381 is a next-generation molecule currently in preclinical testing aimed at addressing gastrointestinal diseases [3]

CALLIPER Trial Results - Vidofludimus Calcium showed a 20% relative risk reduction of 24-week confirmed disability worsening (24wCDW) in the overall study population compared to placebo [38, 89] - In the primary progressive multiple sclerosis (PPMS) subgroup, Vidofludimus Calcium demonstrated an even more prominent 30% relative risk reduction in 24wCDW compared to placebo [38, 89] - Patients without gadolinium-enhancing (Gd+) lesions at baseline experienced a 29% reduction in disability worsening with Vidofludimus Calcium [41, 42, 90] - Vidofludimus Calcium resulted in a 5% improvement in the annualized rate of whole brain atrophy compared to placebo at 24 months [49] - Vidofludimus Calcium substantially reduced the annualized rate of thalamic brain volume loss by 20% compared to placebo at 24 months [49] - The volume of new/enlarging T2 lesions was 319% lower in the Vidofludimus Calcium group compared to the placebo group at month 24 [50, 52] Safety and Tolerability - The trial confirmed a favorable safety and tolerability profile for Vidofludimus Calcium, consistent with previous clinical trials, with similar frequencies of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) in both treatment arms [56, 58, 90] Commercial Opportunity - The market for PPMS treatment is estimated to be over $6 billion, with a significant portion of diagnosed patients currently untreated [72, 74, 85] - Vidofludimus Calcium has a potential peak sales opportunity of $3-7 billion across relapsing MS (RMS), non-active secondary progressive MS (naSPMS), and PPMS indications [76, 80]

About this content About Emily Jarvie Emily began her career as a political journalist for Australian Community Media in Hobart, Tasmania. After she relocated to Toronto, Canada, she reported on business, legal, and scientific developments in the emerging psychedelics sector before joining Proactive in 2022. She brings a strong journalism background with her work featured in newspapers, magazines, and digital publications across Australia, Europe, and North America, including The Examiner, The Advocate, ...

Summary of the Conference Call on CALIBER Trial Results Company and Industry Overview - **Company**: Munich - **Industry**: Multiple Sclerosis (MS) Treatment - **Product**: Beta-flutamious calcium (venoflunomous calcium), a novel treatment for various forms of MS, particularly progressive MS Key Points and Arguments 1. **CALIBER Trial Overview**: The CALIBER Phase II clinical study focused on beta-flutamious calcium for patients with progressive MS, specifically targeting non-active disease forms [4][12] 2. **Patient Demographics**: Approximately 120,000 patients diagnosed with primary progressive MS (PPMS) and 175,000 with secondary progressive MS (SPMS) in the U.S. and EU5 [7][32] 3. **Unmet Medical Need**: There is a significant unmet need in treating disability progression in MS, with only one approved drug for PPMS and no treatments for non-active SPMS [9][10] 4. **Mechanism of Action**: Beta-flutamious calcium is a first-in-class drug that activates NUR1 for neuroprotection and inhibits DHODH to reduce inflammation [6][38] 5. **Study Design**: The trial included 467 patients, focusing on those without recent relapse events, and aimed to assess the drug's neuroprotective effects [17][12] 6. **Results on Disability Worsening**: The trial showed a 20% decrease in confirmed disability worsening events at 24 weeks for beta-flutamious calcium compared to placebo, with a 30% reduction in PPMS patients and 15% in non-active SPMS patients [21][22] 7. **Safety Profile**: No new safety signals were identified, and treatment-emergent adverse events were similar between treatment and placebo groups [29][30] 8. **Market Opportunity**: The global market for primary progressive MS therapies is estimated at $6 billion, with significant potential for beta-flutamious calcium to capture market share due to its unique profile [36][39] 9. **Future Steps**: Discussions with healthcare authorities will determine the next steps for further development and potential approval pathways, including a Phase III trial focusing on PPMS [41][42] Additional Important Insights 1. **Comparison with Existing Treatments**: Current treatments like ocrelizumab have limitations, including safety concerns and administration difficulties, highlighting the need for a more convenient and safer option [34][35] 2. **Potential for Breakthrough Designation**: The company is considering applying for breakthrough designation based on the promising results from the CALIBER trial [42][96] 3. **Long-term Vision**: The company aims to establish beta-flutamious calcium as a cornerstone treatment for both relapsing and progressive forms of MS, with projected peak sales ranging from $3 billion to $7 billion [39][38] 4. **Regulatory Considerations**: The company is preparing for discussions with regulators to ensure the design of the Phase III trial meets approval requirements [62][96] This summary encapsulates the critical findings and strategic implications from the conference call regarding the CALIBER trial results and the future of beta-flutamious calcium in the MS treatment landscape.

Core Insights - Immunic, Inc. announced positive results from its phase 2 CALLIPER trial for vidofludimus calcium (IMU-838) in patients with progressive multiple sclerosis (PMS), showing a 20% reduction in the relative risk of 24-week confirmed disability worsening (24wCDW) events compared to placebo [1][2][8] Clinical Efficacy - In the overall PMS patient population (n=467), vidofludimus calcium reduced the relative risk of 24wCDW events by 20% compared to placebo, with a 30% reduction observed in the primary progressive multiple sclerosis (PPMS) subgroup (n=152) [2][8] - The drug also demonstrated a 15% reduction in the non-active secondary progressive multiple sclerosis (naSPMS) subgroup (n=268) [2] - A consistent reduction in disability worsening was noted in patients without gadolinium-enhancing lesions at baseline, with a 29% reduction in 24wCDW events compared to placebo [4][8] MRI Endpoints - Vidofludimus calcium reduced the annualized rate of thalamic brain volume loss by 20% compared to placebo, indicating a significant neuroprotective effect [5][16] - The total volume of new or enlarging T2 lesions showed a mean percent change of -0.22% for vidofludimus calcium versus +2.97% for placebo at month 24, highlighting the drug's efficacy in reducing lesion formation [6] Safety and Tolerability - The CALLIPER trial confirmed a favorable safety and tolerability profile for vidofludimus calcium, with treatment-emergent adverse events occurring in 69.4% of treated patients compared to 68.5% in the placebo group [9] - Serious adverse events were rare, observed in 8.1% of vidofludimus calcium-treated patients versus 6.5% in the placebo group, with no new safety signals identified [9] Future Directions - The company plans to advance vidofludimus calcium to a phase 3 registration study based on the positive results from the CALLIPER trial, particularly focusing on its potential as a neuroprotective treatment option for PMS [8][11] - Ongoing analysis of the full CALLIPER data set will be presented at upcoming scientific meetings, with the phase 3 clinical trial program for relapsing multiple sclerosis expected to be completed in 2026 [11][17]

Analyst’s Disclosure: I/we have no stock, option or similar derivative position in any of the companies mentioned, but may initiate a beneficial Long position through a purchase of the stock, or the purchase of call options or similar derivatives in IMUX over the next 72 hours. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article. Seeking ...

Core Viewpoint - Immunic, Inc. has successfully closed a registered direct offering of 5,666,667 shares of common stock at a price of $0.90 per share, raising approximately $5.1 million in gross proceeds to fund clinical trials and operations [1][2]. Group 1: Offering Details - The offering was led by Aberdeen Investments and closed on April 10, 2025 [1]. - The gross proceeds from the offering were approximately $5.1 million before deducting commissions and offering expenses [2]. - Titan Partners Group acted as the sole placement agent for the offering [2]. Group 2: Use of Proceeds - The net proceeds from the offering will be used to fund clinical trials, operations, and other general corporate purposes [2]. Group 3: Company Overview - Immunic, Inc. is a biotechnology company focused on developing orally administered, small molecule therapies for chronic inflammatory and autoimmune diseases [5]. - The lead development program, vidofludimus calcium (IMU-838), is in phase 3 and phase 2 clinical trials for multiple sclerosis and has shown therapeutic activity in earlier trials [5]. - Other development programs include IMU-856, targeting gastrointestinal diseases, and IMU-381, which is in preclinical testing [5].

About this content About Emily Jarvie Emily began her career as a political journalist for Australian Community Media in Hobart, Tasmania. After she relocated to Toronto, Canada, she reported on business, legal, and scientific developments in the emerging psychedelics sector before joining Proactive in 2022. She brings a strong journalism background with her work featured in newspapers, magazines, and digital publications across Australia, Europe, and North America, including The Examiner, The Advocate, ...

Core Viewpoint - Immunic, Inc. has announced a registered direct offering of 5,666,667 shares of its common stock at a price of $0.90 per share, aiming to raise approximately $5.1 million to fund clinical trials and operations [1][2]. Group 1: Offering Details - The offering is priced at $0.90 per share, with gross proceeds expected to be around $5.1 million before commissions and expenses [1][2]. - The offering is expected to close on or about April 10, 2025, pending customary closing conditions [2]. - Titan Partners Group is acting as the sole placement agent for the offering [3]. Group 2: Company Overview - Immunic, Inc. is a biotechnology company focused on developing orally administered small molecule therapies for chronic inflammatory and autoimmune diseases [6]. - The lead development program, vidofludimus calcium (IMU-838), is in phase 3 and phase 2 clinical trials for multiple sclerosis and has shown therapeutic activity in earlier trials [6]. - Other development programs include IMU-856, targeting gastrointestinal diseases, and IMU-381, which is in preclinical testing [6].

Company Overview - Immunic, Inc. is a biotechnology company focused on developing orally administered, small molecule therapies for chronic inflammatory and autoimmune diseases [1] - The company's lead development program, vidofludimus calcium (IMU-838), is in phase 3 and phase 2 clinical trials for relapsing and progressive multiple sclerosis, respectively [1] - Vidofludimus calcium has demonstrated therapeutic activity in phase 2 trials for relapsing-remitting multiple sclerosis, progressive multiple sclerosis, and moderate-to-severe ulcerative colitis [1] Product Pipeline - Vidofludimus calcium acts as a first-in-class nuclear receptor related 1 (Nurr1) activator, providing neuroprotective effects and additional anti-inflammatory and anti-viral effects by inhibiting dihydroorotate dehydrogenase (DHODH) [1] - IMU-856 targets Sirtuin 6 (SIRT6) to restore intestinal barrier function and regenerate bowel epithelium, with potential applications in gastrointestinal diseases such as celiac disease and inflammatory bowel disease [1] - IMU-381 is a next-generation molecule in preclinical testing aimed at addressing gastrointestinal diseases [1] Upcoming Conferences - Immunic will participate in the American Academy of Neurology (AAN) 2025 Annual Meeting from April 5-9, 2025, in San Diego, California, with management and medical teams available at booth 2233 [3] - At the German Biotech Days 2025 on April 9-10, 2025, Chief Scientific Officer Hella Kohlhof will present on vidofludimus calcium, highlighting its dual benefits of neuroprotection and relapse prevention [3] - The presentation will be part of a symposium titled "All Grown Up? Mature Biotech Companies Present their Progress" on April 9, 2025 [3]